[Federal Register Volume 88, Number 87 (Friday, May 5, 2023)]
[Proposed Rules]
[Pages 29010-29013]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09640]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2023-0225; FRL-10919-01-OCSPP]
RIN 2070-ZA16


O-Benzyl-P-Chlorophenol (OBPCP); Exemption From the Requirement 
of a Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to exempt residues of the antimicrobial 
pesticide ingredients Ortho-benzyl-para-chlorophenol, Potassium 2-
benzyl-4-chlorophenate, and Sodium 2-benzyl-4-chlorophenate from the 
requirement of a tolerance when used on or applied to food contact 
surfaces in public eating places, dairy processing equipment, and food 
processing equipment and utensils. This rulemaking is proposed on the 
Agency's own initiative under the Federal Food, Drug, and Cosmetic Act 
(FFDCA), in order to implement the tolerance actions EPA identified 
during its review of these chemicals as part of the Agency's 
registration review program under the Federal Insecticide, Fungicide, 
and Rodenticide Act (FIFRA).

DATES: Comments must be received on or before July 5, 2023.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2011-0423, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Anita Pease, Antimicrobials Division 
(7510M), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
(202) 566-0736; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are a 
pesticide manufacturer. The following list of North American Industrial 
Classification System (NAICS) codes is not intended to be exhaustive, 
but rather provides a guide to help readers determine whether this 
document applies to them. Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
https://www.regulations.gov or email. Clearly mark the part or all of 
the information that you claim to be CBI. For CBI information in a disk 
or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM 
as CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.

II. Background

A. What action is the Agency taking?

    EPA is proposing to establish exemptions from the requirement of a 
tolerance for residues of the antimicrobial pesticides Ortho-benzyl-
para-chlorophenol, Potassium 2-benzyl-4-chlorophenate, and Sodium 2-
benzyl-4-chlorophenate on food-contact surfaces in public eating 
places, dairy-processing equipment, and food-processing equipment and 
utensils. EPA is proposing these exemptions to cover residues of Ortho-
benzyl-para-chlorophenol, Potassium 2-benzyl-4-chlorophenate, and 
Sodium 2-benzyl-4-chlorophenate that may be found in food as a result 
of the use of these antimicrobials on food-contact surfaces. This 
tolerance exemption will supersede the current exemption for Ortho-
benzyl-para-chlorophenol under 40 CFR 180.940(c), which is listed as 
Phenol, 4-chloro-2-(phenylmethyl)-, an alternative name for Ortho-
benzyl-para-chlorophenol. The current exemption limits the end-use 
concentration of this substance to 320 ppm in end-use antimicrobial 
solutions. Upon establishment of the new exemption, EPA intends to 
remove the existing exemption as it would be unnecessary and redundant.
    EPA is proposing these tolerance actions to implement the tolerance 
changes identified as necessary during the registration review 
processes to

[[Page 29011]]

cover these pesticide chemical residues when used in antimicrobial 
formulations consistent with current label use directions. Registration 
review documents, such as the draft risk assessment, typically identify 
certain tolerance actions, including modifications to reflect current 
use patterns, meet safety findings, and change commodity names and 
groupings, that may be necessary or appropriate to cover pesticide 
chemical residues or reflect current EPA policy.
    For the pesticide chemicals at issue in this rulemaking, EPA issued 
the ``O-Benzyl-p-Chlorophenol (OBPCP) Interim Registration Review 
Decision'' (OBPCP ID) in November 2019. Electronic copies of the OBPCP 
ID and other documents are available in EPA docket number EPA-HQ-OPP-
2011-0423, which can be found at https://www.regulations.gov. EPA's 
risk assessment for OBPCP contains the Agency's assessment of the 
potential risk associated with current product uses, and based on the 
findings of that risk assessment, the OBPCP ID identified the need to 
establish exemptions from the requirement of a tolerance for Ortho-
benzyl-para-chlorophenol, Potassium 2-benzyl-4-chlorophenate, and 
Sodium 2-benzyl-4-chlorophenate on food-contact surfaces in public 
eating places, dairy-processing equipment, and food-processing 
equipment and utensils.

B. What is the Agency's authority for taking this action?

    Section 408(e) of the FFDCA authorizes EPA to establish exemptions 
from the requirement of a tolerance. 21 U.S.C. 346a(e)(1)(B). Before 
issuing the final exemption, EPA is required to issue a proposed 
rulemaking and provide a comment period. Id. at 346a(e)(2).
    A ``tolerance'' represents the maximum level for residues of 
pesticide chemicals legally allowed in or on raw agricultural 
commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 346a, 
authorizes the establishment, modification, and revocation of 
tolerances and exemptions from the requirement of a tolerance for 
residues of pesticide chemicals in or on raw agricultural commodities 
and processed foods. Residues of pesticides in or on food that are not 
covered by a tolerance or exemption are deemed unsafe, 21 U.S.C. 
408(a), and any food containing unsafe residues is considered 
adulterated under FFDCA section 402(a), 21 U.S.C. 342(a). Such food may 
not be distributed in interstate commerce, 21 U.S.C. 331(a). For a 
food-use pesticide to be sold and distributed, the pesticide must not 
only have appropriate tolerances under the FFDCA but also must be 
registered under FIFRA, 7 U.S.C. 136 et seq. Moreover, residues of 
food-use pesticides not registered in the United States must also be 
covered by a U.S. tolerance or exemption in order for commodities 
treated with those pesticides to be imported into the United States.
    Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemption from the requirement of a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) of the FFDCA 
defines ``safe'' to mean that ``there is a reasonable certainty that no 
harm will result from aggregate exposure to the pesticide chemical 
residue, including all anticipated dietary exposures and all other 
exposures for which there is reliable information.'' 21 U.S.C. 
346a(c)(2)(A)(ii). This includes exposure through drinking water and in 
residential settings but does not include occupational exposure. 
Section 408(c)(2)(B) of the FFDCA requires EPA, when making a safety 
determination concerning an exemption, to take into account, among 
other relevant considerations, the considerations listed in section 
408(b)(2)(C) and (D) of the FFDCA. Section 408(b)(2)(C) of the FFDCA 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue. . . .'' Section 408(b)(2)(D) identifies various 
factors, including available information on aggregate and cumulative 
exposure, for EPA consideration in making a safety determination.

C. When do these actions become effective?

    EPA is proposing that these tolerance actions become effective on 
the date of publication of the final rule in the Federal Register.

III. Proposed Rule

    EPA is proposing this rule to implement the tolerance actions 
identified in the OBPCP ID. As noted in the November 2019 OBPCP ID, 
there is an exemption from the requirement of a tolerance under 40 CFR 
180.940(c) for residues of Ortho-benzyl-para-chlorophenol resulting 
from applications to food-processing equipment and utensils, with the 
limitation that the end-use concentration of Ortho-benzyl-para-
chlorophenol does not exceed 320 ppm. During registration review, EPA 
determined that Ortho-benzyl-para-chlorophenol, Potassium 2-benzyl-4-
chlorophenate, and Sodium 2-benzyl-4-chlorophenate were also registered 
for use in public eating areas and on dairy-processing equipment, as 
well as at a higher rate on food-processing equipment and utensils; 
therefore, there is a need to establish additional exemptions for 
residues resulting from these registered uses. EPA, on its own 
initiative, is proposing to establish the necessary exemptions under 40 
CFR 180.940(a), which would cover all food-contact uses of Ortho-
benzyl-para-chlorophenol, Potassium 2-benzyl-4-chlorophenate, and 
Sodium 2-benzyl-4-chlorophenate pesticide products, when used in 
antimicrobial formulations not to exceed a concentration of 2,080 ppm 
in the end-use formulation. When established, the 180.940(a) exemption 
will supersede the current exemption in 40 CFR 180.940(c) for 
registrations containing Ortho-benzyl-para-chlorophenol up to 320 ppm 
used on food processing equipment and utensils.
    In order to establish tolerances or exemptions from the requirement 
of a tolerance, EPA is required to determine that each tolerance or 
exemption meets the safety standard of FFDCA. In its risk assessment 
supporting the OBPCP ID, EPA considered the potential risks from 
exposure to Ortho-benzyl-para-chlorophenol, Potassium 2-benzyl-4-
chlorophenate, and Sodium 2-benzyl-4-chlorophenate from registered uses 
and concluded that those uses did not present risks of concern. See 
U.S. EPA, Registration Review Draft Risk Assessment for: O-Benzyl-P-
Chlorophenol (OBPCP) and Salts (OBPCP DRA), available at https://www.regulations.gov in docket ID number EPA-HQ-OPP-2011-0423.

A. Aggregate Risk Assessment and Determination of Safety

    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure to support the establishment 
of exemptions from the requirement of a tolerance for residues of 
Ortho-benzyl-para-chlorophenol, Sodium 2-benzyl-4-chlorophenate, and 
Potassium 2-benzyl-4-chlorophenate.
    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the

[[Page 29012]]

studies to human risk. EPA has also considered available information 
concerning the variability of the sensitivities of major identifiable 
subgroups of consumers, including infants and children.
    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime.
    EPA's risk assessment Ortho-benzyl-para-chlorophenol, Potassium 2-
benzyl-4-chlorophenate, and Sodium 2-benzyl-4-chlorophenate can be 
found in full at https://www.regulations.gov in docket ID number EPA-
HQ-OPP-2011-0423. That document explains EPA's analysis of the toxicity 
of the pesticide chemicals as well as the selection of toxicological 
points of departure and levels of concern for use in evaluating the 
risk posed by human exposure to the pesticide. In addition, that 
document is based on the maximum label rate for commercial use.
    The Agency did not identify any dietary or aggregate risks of 
concern for Ortho-benzyl-para-chlorophenol, Sodium 2-benzyl-4-
chlorophenate, and Potassium 2-benzyl-4-chlorophenate during the risk 
assessment.
    Based on the lack of any aggregate risks of concern, EPA concludes 
that these exemptions from the requirement of a tolerance for residues 
of Ortho-benzyl-para-chlorophenol, Sodium 2-benzyl-4-chlorophenate, and 
Potassium 2-benzyl-4-chlorophenate, including the limitation for the 
end-use formulation concentration of each of these pesticides does not 
exceed 2,080 ppm, are safe, i.e., there is a reasonable certainty that 
no harm will result from aggregate exposures to Ortho-benzyl-para-
chlorophenol, Sodium 2-benzyl-4-chlorophenate, or Potassium 2-benzyl-4-
chlorophenate, when used in accordance with the terms of the respective 
exemptions. In addition, EPA has determined that there is a reasonable 
certainty that no harm will result to infants and children from 
aggregate exposure to the pesticide chemical residues, in accordance 
with FFDCA section 408(b)(2)(C).

B. Conclusion

    Therefore, EPA is proposing to establish exemptions in 40 CFR 
180.940(a) for residues of the antimicrobial pesticide ingredients 
Ortho-benzyl-para-chlorophenol, Potassium 2-benzyl-4-chlorophenate, and 
Sodium 2-benzyl-4-chlorophenate from the requirement of a tolerance 
when used on or applied to food contact surfaces in public eating 
places, dairy processing equipment, and food processing equipment and 
utensils, with a limitation in concentration of 2,080 ppm in end-use 
formulations. In addition, EPA is proposing to remove the existing 
exemption in 40 CFR 180.940(c) the exemption for Phenol, 4-chloro-2-
(phenylmethyl)-, as it will be superseded by these new exemptions.

IV. Statutory and Executive Order Reviews

    In this proposed rule, EPA is proposing to exempt residues of the 
antimicrobial pesticide ingredients Ortho-benzyl-para-chlorophenol, 
Potassium 2-benzyl-4-chlorophenate, and Sodium 2-benzyl-4-chlorophenate 
from the requirement of a tolerance when used on or applied to food 
contact surfaces in public eating places, dairy processing equipment, 
and food processing equipment and utensils. This document is proposing 
to establish exemptions from the requirement of a tolerance under FFDCA 
section 408(e), and also remove a specific exemption as no longer 
necessary. The Office of Management and Budget (OMB) has exempted these 
types of actions (e.g., establishment and modification of a tolerance 
and tolerance revocation for which extraordinary circumstances do not 
exist) from review under Executive Order 12866, entitled ``Regulatory 
Planning and Review'' (58 FR 51735, October 4, 1993). Because this 
proposed rule has been exempted from review under Executive Order 12866 
due to its lack of significance, this proposed rule is not subject to 
Executive Order 13211, entitled ``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 
28355, May 22, 2001). This proposed rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.,) or impose any enforceable 
duty or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). Nor does 
it require any special considerations as required by Executive Order 
12898, entitled ``Federal Actions to Address Environmental Justice in 
Minority Populations and Low-Income Populations'' (59 FR 7629, February 
16, 1994); or OMB review or any other Agency action under Executive 
Order 13045, entitled ``Protection of Children from Environmental 
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). This 
proposed rule does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note). Pursuant to the Regulatory 
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency previously 
assessed whether establishment of tolerances, exemptions from 
tolerances, raising of tolerance levels, expansion of exemptions, or 
revocations might significantly impact a substantial number of small 
entities and concluded that, as a general matter, these actions do not 
impose a significant economic impact on a substantial number of small 
entities. These analyses for tolerance establishments and 
modifications, and for tolerance revocations were published in the 
Federal Register of May 4, 1981 (46 FR 24950) and December 17, 1997 (62 
FR 66020) (FRL-5753-1), respectively, and were provided to the Chief 
Counsel for Advocacy of the Small Business Administration. Taking into 
account this analysis, and available information concerning the 
pesticides listed in this proposed rule, the Agency hereby certifies 
that this proposed rule will not have a significant negative economic 
impact on a substantial number of small entities. Furthermore, for the 
pesticide named in this proposed rule, the Agency knows of no 
extraordinary circumstances that exist as to the present proposed rule 
that would change EPA's previous analysis. Any comments about the 
Agency's determination should be submitted to the EPA along with 
comments on the proposed rule and will be addressed prior to issuing a 
final rule. In addition, the Agency has determined that this proposed 
rule will not have a substantial direct effect on States, on the 
relationship between the National Government and the States, or on the

[[Page 29013]]

distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled 
``Federalism'' (64 FR 43255, August 10, 1999). Executive Order 13132, 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by State and local officials in the development of 
regulatory policies that have federalism implications.'' ``Policies 
that have federalism implications'' is defined in the Executive order 
to include regulations that have ``substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government.'' This proposed rule directly regulates 
growers, food processors, food handlers, and food retailers, not 
States. This proposed rule does not alter the relationships or 
distribution of power and responsibilities established by Congress in 
the preemption provisions of FFDCA section 408(n)(4). For these same 
reasons, the Agency has determined that this proposed rule does not 
have any ``tribal implications'' as described in Executive Order 13175, 
entitled ``Consultation and Coordination with Indian Tribal 
Governments'' (65 FR 67249, November 9, 2000). Executive Order 13175, 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal Government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal Government and Indian tribes.'' This proposed rule will not 
have substantial direct effects on tribal governments, on the 
relationship between the Federal Government and Indian tribes, or on 
the distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this proposed rule.

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: May 1, 2023.
Edward Messina,
Director, Office of Pesticide Programs.

    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.940:
0
a. Amend paragraph (a) the table by, adding in alphabetical order, the 
entries ``Ortho-benzyl-para-chlorophenol''; ``Potassium 2-benzyl-4-
chlorophenate'' and ``Sodium 2-benzyl-4-chlorophenate''.
0
b. Amend paragraph (c) the table by removing the entry for ``Phenol, 4-
chloro-2-(phenylmethyl)-''.
    The additions read as follows:


Sec.  180.940  Tolerance exemptions for active and inert ingredients 
for use in antimicrobial formulations (Food-contact surface sanitizing 
solutions).

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           Pesticide chemical                          CAS reg. No.                           Limits
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Ortho-benzyl-para-chlorophenol..........  120-32-1.............................  When ready for use, the end-use
                                                                                  concentration is not to exceed
                                                                                  2080 ppm.
 
                                                  * * * * * * *
Potassium 2-benzyl-4-chlorophenate......  35471-49-9...........................  When ready for use, the end-use
                                                                                  concentration is not to exceed
                                                                                  2080 ppm.
 
                                                  * * * * * * *
Sodium 2-benzyl-4-chlorophenate.........  3184-65-4............................  When ready for use, the end-use
                                                                                  concentration is not to exceed
                                                                                  2080 ppm.
 
                                                  * * * * * * *
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[FR Doc. 2023-09640 Filed 5-4-23; 8:45 am]
BILLING CODE 6560-50-P


